Clearstone Reporting HbA1c Result Values in IFCC and NGSP Units for All Clinical Trials Globally

Company News Release

Clearstone Central Laboratories announced the company is reporting HbA1c result values in International Federation of Clinical Chemistry (IFCC) units as well as the National Glycohemoglobin Standardization Program (NGSP) standard units.
 
“Worldwide, many countries including most European countries, Japan and Australia have decided to change to IFCC units with a transition period of dual reporting” said Patrice Hugo, PhD, Clearstone’s Chief Scientific Officer. “We have been watching this issue very closely to advise our clients, and are pleased to offer the availability of both measurements for all studies through APOLLO CLPM™, our proprietary central laboratory protocol management system”.
 
As a result of having two reference standards for the measurement of HbA1c, Clearstone has made both reporting formats available to clients: IFCC (mmol/mol) and derived NGSP units (%).  The correlation between these two is well documented, has been stable and is described by a robust equation: IFCC = (10.93 x NGSP) - 23.50.  With this IFCC/NGSP master equation, all laboratories can provide derived units in either format.  As recommended by the American Diabetes Association (ADA), Clearstone will continue to use an HbA1c threshold of 6.4% (46 mmol/mol) as the upper limit of normal.